Submission Type: BLA Submission ID: 125363/0 Office: OVRR
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Telecon Date/Time: 13-Oct-2011 03:30 PM Initiated by FDA? Yes
Telephone Number: firstname.lastname@example.org
Author: KIRK PRUTZMAN
Item 2.b.i Clarification Response
FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK, DAVID STATEN
Non-FDA Participants: JODY GOULD
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Prutzman, Kirk C
Sent: Thursday, October 13, 2011 3:25 PM
To: 'Jody Gould'
Cc: Temenak, Joseph; Staten, David
Subject: RE: BL/STN 125363 MenHibrix - Request for Clarification
We have received a response from our review team regarding clarification of Item 2.b.i. Briefly, the reviewer is concerned about the impact of the –b(4)---------- on the variance of the samples that would be dependent on the titer of the sample. This is essentially your "second suggestion" in your email below. Let me know if this needs further clarification.
Regarding your submission of Item 26. Sean Byrd has received the manual visual inspection data and is currently reviewing it. There are no comments at this time.
We have also received your intent to file amendment.
From: Jody Gould [mailto:email@example.com]
Sent: Wednesday, September 28, 2011 11:43 AM
To: Prutzman, Kirk C
Subject: BL/STN 125363 MenHibrix - Request for Clarification
I am writing to request clarification on one question in the September 21 CR letter.
Specifically, we would like clarification of the sentence in Item 2.b.i: Please show that the –b(4)-------- algorithm is independent of sample titer, i.e., that the variance of the --b(4)---------- ratio is constant relative to titer.
Could the reviewer please clarify if this refers to variation of the variance due to the titers of the controls, or to an impact of the ---b(4)------- factor on the variance of the samples that would be dependent on the samples’ titers.
Note that we may have additional items for clarification as we continue to review the letter and assess CBER’s requests in detail.
Also, in case you haven’t seen them yet:
- Manual visual inspection information (response to request from S. Byrd) was submitted on September 23.
- Intent to File Amendment was submitted on September 26.
Jody Ann Gould, PhD
US Regulatory Affairs
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